The National Institute of Allergy and Infectious Diseases (NIAID, has awarded the company a Direct to Phase II Small Business Innovation Research (SBIR) grant of approximately $2.97 million to continue development of a novel, pan-flu multivariant mucosal vaccine.
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TFF Pharmaceuticals announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded the Company a Direct to Phase II Small Business Innovation Research (SBIR) grant of approximately $2.97 million to continue development of a novel, pan-flu multivariant mucosal vaccine using the Company’s Thin Film Freezing technology.
The purpose of the SBIR is to provide funding to support preclinical and IND enabling studies to advance the development of a shelf-stable dry powder formulation of a novel universal influenza virus vaccine, developed in the laboratory of Dr. Ted Ross at the Cleveland Clinic (previously of University of Georgia), that is more than 75% effective against symptomatic influenza virus infection and protects against groups I and II influenza A viruses, the form of virus that has historically given rise to all known influenza pandemics and that contributes to seasonal flu each year.
If successful, this work could provide a first-in-class stable, easy-to-transport and easy-to-stockpile vaccine that would overcome the vaccine failures that result from mishandling, mismatches between predicted and actual seasonal flu strains, and evolutionary changes in influenza viruses across the season.
Successful completion of this Direct to Phase II SBIR grant will fulfill the IND-enabling requirements to potentially advance to human clinical testing.
More specifically, the research from this grant will evaluate different adjuvants for intranasal and pulmonary inhalation delivery and confirm the stability, immunogenicity, and efficacy of the TFF-formulated HA vaccine in ferrets, the gold standard for influenza virus vaccine testing.
Additional research includes tests to evaluate scale up manufacturing of the vaccine, complete GLP toxicology studies, and upon successful completion, advancement of the vaccine candidate to IND and human studies.
Funding from the SBIR grant is expected to take place over three years. ■